Vessel Due F capsules 250 LE, 60pcs

Composition

Each capsule contains: Active ingredient: sulodexide 250 LE*Excipients: sodium lauryl sarcosinate 3.30 mg, colloidal silicon dioxide 2.00 mg, triacetin 83.87 mg. Capsule shell components: gelatin 53.15 mg, glycerol 22.07 mg, sodium ethyl parahydroxybenzoate 0.26 mg, sodium propyl parahydroxybenzoate 0.13 mg, titanium dioxide (E 171) 0.29 mg, iron oxide red (E 172) 0.86 mg. * – lipoprotein lipase unit

Pharmacological action

Wessel ® Dual F (sulodexide) is a biologic drug that is a natural blend of glycosaminoglycans (GAGS): a heparin-like fraction with a molecular weight of 8000 daltons (80%) and dermatan sulfate (20%). The mechanism of action of sulodexide is determined by two main properties:  The fast-acting heparin-like fraction has an affinity for antithrombin III (ATIII), and the dermatan fraction has an affinity for heparin cofactor II (KGII). After oral use at the recommended dosage, the amount of sulodexide and its derivatives after the first pass effect is sufficient to induce antithrombin action without affecting the usual coagulation parameters (activated partial thromboplastin time (APTT), thrombin time, activated factor X). Thus, it can be assumed that sulodexide when administered orally does not have an anticoagulant effect Pharmacological action: angioprotective, profibrinolytic, antithrombotic. Pharmacodynamicangioprotective action is associated with the restoration of the structural and functional integrity of vascular endothelial cells, with the restoration of the normal density of the negative electric charge of the pores of the basal membrane of vessels. In addition, the drug normalizes the rheological properties of blood by reducing the level of triglycerides (it stimulates the lipolytic enzyme lipoprotein lipase, which hydrolyzes triglycerides that are part of LDL). The effectiveness of the drug in diabetic nephropathy is determined by the ability of sulodexide to reduce the thickness of the basement membrane and the production of extracellular matrix by reducing the proliferation of mesangium cells. The profibrinolytic effect is caused by an increase in the level of tissue plasminogen activator in the blood and a decrease in the content of its inhibitor. The antithrombotic activity of sulodexide administered orally is mainly the result of all the effects that sulodexide has on the vascular wall (angioprotective effect), fibrinolysis (profibrinolytic effect) and inhibition of platelet adhesion. Pharmacokineticsasulodexide is absorbed in the small intestine. After oral use of the labeled drug, the first peak of sulodexide in blood plasma is observed after 2 hours, the second-from 4 to 6 hours, after which the drug is no longer detected in plasma; the concentration is restored after approximately 12 hours, and then remains constant until about 48 hours. A constant level in the blood plasma is detected after 12 hours, probably due to the slow release of the drug by the absorption organs and, in particular, by the vascular endothelium. Sulodexide is distributed in the vascular endothelium at a concentration 20-30 times higher than that in other tissues. It is metabolized in the liver and is mainly excreted by the kidneys. In the study of a radiolabeled preparation,55.23% of sulodexide was excreted in the urine during the first 96 hours.

Indications

• angiopathy with increased risk of thrombosis, including after myocardial infarction;
• cerebrovascular disease, including acute ischemic stroke and early recovery; dyscirculatory encephalopathy caused by atherosclerosis, diabetes, hypertension; vascular dementia;
• occlusive peripheral artery as atherosclerotic and diabetic Genesis;
• of phlebopathy, deep venous thrombosis;
• microangiopathy (nephropathy, retinopathy, neuropathy) and macroangiopathy in diabetes (diabetic foot syndrome, encephalopathy, cardiomyopathy);
• thrombophilic disorders, antiphospholipid syndrome (administered in conjunction with acetylsalicylic acid, as well as after low molecular weight heparins);
• treatment heparinization thrombotic thrombocytopenia, as it causes and doesn’t aggravate it.

Contraindications

-hypersensitivity; – hemorrhagic diathesis and diseases accompanied by reduced blood clotting; – pregnancy of the first trimester. With caution: When combined with anticoagulants, blood clotting parameters should be monitored.

Side effects

According to clinical studiesdata on the incidence of adverse drug reactions associated with the use of sulodexide were obtained during clinical studies involving patients treated with standard doses of the drug with the usual duration of therapy. Sulodexide-related adverse reactions were classified by systemic-organ class and distributed by frequency in the following order: very common (≥ 1/10), common (≥ 1/100 to < 1/10), infrequent (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (Nervous system: infrequently-headache, very rarely-loss of consciousness. Organ of hearing: often – dizziness. Gastrointestinal tract: often-upper abdominal pain, diarrhea, nausea, infrequently-abdominal discomfort, dyspepsia, flatulence, vomiting, very rarely – gastric bleeding. Allergic reactions: often-skin rash of various localization, infrequently-eczema, erythema, urticaria. Based on post-registration observations. Additional adverse events were reported during post-marketing use of sulodexide. The frequency of these undesirable effects cannot be estimated due to the fact that information about them comes in the form of spontaneous messages. Accordingly, the frequency of these adverse events is classified as “unknown” (cannot be calculated based on available data). Anemia, disorders of plasma protein metabolism, disorders of the gastrointestinal tract, melena, angioedema, ecchymosis, genital edema, genital erythema, polymenorrhea.

Interaction

No significant interaction of Wessel® Due F with other drugs has been established. When using sulodexide, it is not recommended to simultaneously use drugs that affect the hemostatic system as anticoagulants (direct and indirect).

How to take, course of use and dosage

1-2 capsules 2 times a day before meals for 30-40 days. Usually, treatment begins with the use of the drug in the dosage form “solution for intravenous and intramuscular use”,1 ampoule per day, intramuscularly or intravenously, for 15-20 days. The full course of treatment should be repeated at least 2 times a year. Depending on the results of the patient’s clinical and diagnostic examination, the dosage regimen may be changed at the discretion of the doctor.

Overdose

Bleeding is the only phenomenon that can occur with overdose. In case of bleeding, it is necessary to introduce protamine sulfate (1% solution), which is used for bleeding caused by heparin.

Special instructions

Due to the pharmaco-toxicological properties of sulodexide, the use of the drug does not require special precautions. However, when co-administered with other anticoagulants, blood clotting parameters should be monitored periodically. Effect on the ability to drive vehicles and mechanismmin the ability to drive vehicles and mechanisms is not affected by Wessel® Due F.

Active ingredient

Sulodexide

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Description

For adults as prescribed by a doctor, Pregnant women in the second and third trimester as prescribed by a doctor, Nursing mothers as prescribed by a doctor

Indications

Diabetic retinopathy, Prevention of thrombosis, Cerebral circulation disorders, Diabetic nephropathy, Vascular lesions in diabetes mellitus, Thrombophlebitis, Consequences of stroke